Category: Policy Updates

21st Century Cures Act Passes House with Overwhelming Bipartisan Support

This morning, the U.S. House of Representatives passed (344-77) the 21st Century Cures Act. This is a monumental achievement, designed to fundamentally restructure the Food and Drug Administration and thereby reverse the staggering decline of productivity in medical research and development.

The bill started as a bipartisan effort in the House Energy & Commerce Committee, where Republican and Democratic leaders moved beyond rhetoric and went right back to the basics, questioning the role of the federal government in spurring innovation and regulating our access to medical technology.

Unfortunately, their achievement is tainted by another fiscal glitch. For the third time (after the Medicare “doc fix” and repeal of the medical device excise tax), the House has voted for spending while weakening its commitment to offsetting cuts.

One Fifth of States Join Interstate Medical Licensure Compact

StethoscopeIowa has become the tenth state to enact the Interstate Medical Licensure Compact, which will ease the licensing of physicians outside their home states. This is a great achievement for the medical profession and state sovereignty. For almost a year now, I have been supporting this effort and I am glad to see it succeeding.

On June 24, I attended a briefing conducted in the wake of the compact hitting seven members. This started the wheels turning to establish a commission that will actually execute and administer the interstate licensing of physicians. At the meeting I learned a few things, a couple of which surprised me:

Leaked: Obama’s Trade Deal Includes Strong Intellectual Property Rights

I had been concerned that the Trade Promotion Authority, which Congress just granted the president, would be problematic because the president would not push for strong intellectual property protection in international trade agreements, especially the Trans Pacific Partnership.

I am glad to learn that I was wrong (or that the administration heeded my concerns):

A recent draft of the Trans-Pacific Partnership free-trade deal would give U.S. pharmaceutical firms unprecedented protections against competition from cheaper generic drugs, possibly transcending the patent protections in U.S. law.

The draft text includes provisions that could make it extremely tough for generics to challenge brand-name pharmaceuticals abroad. Those provisions could also help block copycats from selling cheaper versions of the expensive cutting-edge drugs known as “biologics” inside the U.S……

(Michael Grunwald, “Leaked: What’s in Obama’s trade deal,” Politico, June 2015)

When the official draft comes out, this will cause lots of controversy in the U.S. and abroad.

Trans-Pacific Partnership: Intellectual Property Rights Won’t be Strong Enough

A few days ago, I discussed my concern that intellectual property rights for pharmaceutical innovators would not be strong enough in the Trans-Pacific Partnership agreement for which President Obama seeks Trade Promotion Authority.

Well, they won’t be strong enough, according to information leaked from the negotiations:

Facing resistance from Pacific trading partners, the Obama administration is no longer demanding protection for pharmaceutical prices under the 12-nation Trans-Pacific Partnership, according to a newly leaked section of the proposed trade accord.

But Pacific accord negotiators appear ready to grant pharmaceutical and medical device makers more power to influence participating governments. The 12 countries involved, and any others that might join later, would have to disclose rules and guidelines for deciding which medical products would be made available through government programs and at what rate providers would be reimbursed.

(Jonathan Weisman, “U.S. Shifts Stance on Drug Pricing in Pacific Trade Pact Talks, Document Reveals,” New York Times, June 10, 2015)

Call me old-fashioned, but I think that’s a pretty reasonable request.

Electronic Health Records: Physicians, Hospitals “Literally Terrified” of Next Stage

In a hearing on Meaningful Use Stage 3, interoperability and patient access to data, Sen. Lamar Alexander (R-Tenn.) cut right to the heart of the problem.

“To put it bluntly, physicians and hospitals have said to me that they are literally terrified of the next implementation stage … because of the complexity and because of the fines that will be levied,” he said. (Katie Dvorak, FierceHealthIT, June 10, 2015)

Well, okay, but let us recall that these doctors and hospitals were happy to take the almost $30 billion of taxpayers’ money the government handed them to install the Electronic Health Records subject to these regulations

Calorie Counts on Menus Don’t Work

Obamacare mandates that chain restaurants post calorie counts on menu boards. This is an example of “nudging.” Wouldn’t it be great if America’s obesity epidemic could be solved by just ensuring people are better informed about how many calories are in those French fries?

Well, the evidence is in, and calorie counts are ineffective. Dr. Aaron Carroll tells the story at his always informative and engaging Healthcare Triage YouTube channel:

I had the pleasure of meeting Dr. Carroll recently at the National Institute for Health Care Management Foundation’s Health Care Digital Awards dinner, where he won well deserved recognition. All I can add to Dr. Carroll’s explanation of the evidence is an argument for why the government finds this nudging irresistible.

Trans-Pacific Partnership: Will Intellectual Property Rights Be Strong Enough?

Having passed the Senate, it is now up to the House of Representatives to decide whether to give President Obama Trade Promotion Authority (TPA, or “fast track”) to negotiate the Trans-Pacific Partnership.

Most Congressional Republicans who support TPA also advocate strong intellectual property rights. However, one concern with TPA is that it is uncertain the President will negotiate strong intellectual property rights in the TPP. What will these Republicans do if the final version of the TPP does not have adequate protection for investment in intellectual property?

One example is the protection of data exclusivity for inventors of new biotech products. The U.S. has the gold standard – 12 years – and it is reasonable to seek this standard in the TPP.

When it comes to pharmaceutical patents, U.S. Senator Orrin Hatch is on the side of protection intellectual property with respect to current trading partners. He recently criticized the president for not doing enough to pressure India (which is not in the TPP) to improve its patent protection.

On the other hand, he was the Senate champion for fast track for TPP. Is this consistent?

Doctors, Hospitals, Medical Groups Demand EHR Rule Delay

electronic-medical-recordElectronic Health Records (EHRs) continue to take on water:

Calls for the Centers for Medicare & Medicaid Services to refrain from finalizing Meaningful Use Stage 3 are increasing, with the American Medical Association and the Medical Group Management Association adding their voices to the din.

Both organizations cite concerns over the proposed rule as it currently stands, with AMA saying in a letter to CMS Acting Administrator Andy Slavitt and National Coordinator for Health IT Karen DeSalvo that the program “will create significant challenges for physicians, patients, and vendors.”

MGMA adds in its own letter to Slavitt that Stage 3 could result in a failure to meet the goals outlined in the American Recovery and Reinvestment Act of 2009. It should be delayed, MGMA says, until it is known what the impact of Medicare Access and CHIP Reauthorization Act of 2015 will be. (Katie Dvorak, FierceEMR, June 3, 2015).

I discussed the stage 3 rule when it was published. The response of these professional groups is stunning: They were all happy to take the almost $30 billion the government handed out to induce them to install Electronic Health Records.

And they led Congress by the nose just a few weeks go to pass the flawed Medicare Access and CHIP Reauthorization Act. At the time, none of them mentioned it was going to increase the burden of EHR compliance. The first organization to explain this consequence was the NCPA, in report I wrote before the law passed. These groups are asking the government for relief from a flawed so-called Medicare “doc fix” for which they themselves had spent years lobbying.

Republican Study Committee Reintroduces Health Reform Bill

The RSC has re-introduced its American Health Care Reform Act, previously introduced in September 2013.

Most importantly, it eliminates the current exclusion from taxable income of employer-based benefits as well as Obamacare’s tax credits paid through exchanges. Instead, it offers a standard deduction of $7,500 for individuals or $20,500 for a family that buys qualifying health insurance.

Why Don’t You Own Your Own Health Data?

David Brailer, MD, was the first head of the Office of the National Coordinator of Health Information Technology (ONC), appointed by President George W. Bush. Today, he is a venture capitalist.

In today’s Wall Street Journal, Dr. Brailer notes that a law passed in 1996 governs our access to health information. Clearly, it needs updating:

This brave new digital world has one huge risk: You don’t own your health information. In 1996 the U.S. passed a law called HIPAA (Health Insurance Portability and Accountability Act) requiring hospitals, physicians, labs, pharmacies and other “covered entities” as well as the health plans and their “business associates” (for example, an information-technology vendor) to protect how your data is stored and released. But not without delays, often for months. You can’t force a covered entity to give your data to someone you choose, and you can’t stop them from giving it to someone they choose. Health apps? Most aren’t covered by HIPAA at all, and can do whatever they want with your information.

It is a fascinating indictment by someone with unique expertise in the field. Dr. Brailer is demanding a substantial rewrite to current law. He is also deflating ONC’s assertions that it is succeeding in granting patients ownership of our health data.

I participated in a meeting in September 2013, in which Dr. Brailer’s charismatic and enthusiastic successor, Dr. Farzad Mostashari, repeatedly announced that he and his colleagues had (gulp) “created” – not even “discovered” or “defined” – a “new right” for patients to access our data. The notion that government agencies “create” rights should obviously be anathema in the United States.

However, another major obstacle to solving the problem Dr. Brailer identifies is that health insurers control most of our health spending. They also want to control our data. As long as this is the case, we patients will struggle to own our health data in any meaningful senses.

Only when patients directly control payment to providers will providers respect patients’ ownership of our own health data.